Instituto de Pesquisa Clínica Evandro Chagas, HIV/AIDS Clinical Research Center, Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, RJ, Brazil.
Instituto de Pesquisa Clínica Evandro Chagas, HIV/AIDS Clinical Research Center, Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, RJ, Brazil; Departamento de Matemática, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil.
Braz J Infect Dis. 2014 Jan-Feb;18(1):34-41. doi: 10.1016/j.bjid.2013.04.005. Epub 2013 Sep 9.
Toxicity is the most frequently reported reason for modifying or discontinuing the first combined antiretroviral therapy regimens, and it can cause significant morbidity, poor quality of life and also can be an important barrier to adherence, ultimately resulting in treatment failure and viral resistance. Elderly patients with HIV/AIDS (≥ 50 years) may have a different profile in terms of treatment modification due to higher incidence of comorbidities and polypharmacy. The aim of this study was to describe the incidence of modifying or discontinuing first combined antiretroviral therapy regimen due to toxicity (TOX-MOD) during the first year of treatment at the IPEC - FIOCRUZ HIV/AIDS cohort, Rio de Janeiro, Brazil, stratified by age. Demographic, clinical and treatment characteristics from antiretroviral-naïve patients who first received combined antiretroviral therapy between Jan/1996 and Dec/2010 were collected. Incidence rate and confidence interval of each event were estimated using quasipoisson model. To estimate hazard ratio (HR) of TOX-MOD during the first year of combined antiretroviral therapy Cox's proportional hazards regression was applied. Overall, 1558 patients were included; 957 (61.4%), 420 (27.0%) and 181 (11.6%) were aged <40, 40-49, and ≥ 50 years, respectively. 239 (15.3%) events that led to any modifying or discontinuing within the first year of treatment were observed; 228 (95.4%) of these were TOX-MOD, corresponding to an incidence rate of 16.6/100 PY (95% CI: 14.6-18.9). The most frequent TOX-MOD during first combined antiretroviral therapy regimen were hematologic (59; 26.3%), central nervous system (47; 20.9%), rash (42; 19.1%) and gastrointestinal (GI) (38; 16.7%). In multivariate analysis, incidence ratio of TOX-MOD during the first year of combined antiretroviral therapy progressively increases with age, albeit not reaching statistical significance. This profile was maintained after adjusting the model for sex, combined antiretroviral therapy regimen and year of combined antiretroviral therapy initiation. These results are important because not only patients are living longer and aging with HIV, but also new diagnoses are being made among the elderly. Prospective studies are needed to evaluate the safety profile of first line combined antiretroviral therapy on elderly individuals, especially in resource-limited countries, where initial regimens are mostly NNRTI-based.
毒性是修改或停止首次联合抗逆转录病毒治疗方案最常报告的原因，它会导致严重的发病率、生活质量下降，并且也是导致依从性差的一个重要因素，最终导致治疗失败和病毒耐药。HIV/AIDS 老年患者（≥50 岁）由于合并症和多药治疗的发生率较高，治疗方案的修改可能会有所不同。本研究的目的是描述巴西里约热内卢 IPEC-FIOCRUZ HIV/AIDS 队列中，在治疗的第一年因毒性（TOX-MOD）而修改或停止首次联合抗逆转录病毒治疗方案的发生率，该队列按年龄分层。对 1996 年 1 月至 2010 年 12 月期间首次接受联合抗逆转录病毒治疗的抗逆转录病毒初治患者的人口统计学、临床和治疗特征进行了收集。使用拟泊松模型估计每个事件的发生率和置信区间。为了估计第一年联合抗逆转录病毒治疗期间 TOX-MOD 的风险比（HR），应用了 Cox 比例风险回归。共纳入 1558 例患者；957（61.4%）、420（27.0%）和 181（11.6%）例患者年龄分别<40、40-49 和≥50 岁。观察到治疗的第一年中发生的任何修改或停药的 239（15.3%）事件，其中 228（95.4%）为 TOX-MOD，发生率为 16.6/100 PY（95%CI：14.6-18.9）。在首次联合抗逆转录病毒治疗方案中最常见的 TOX-MOD 是血液学（59；26.3%）、中枢神经系统（47；20.9%）、皮疹（42；19.1%）和胃肠道（GI）（38；16.7%）。多变量分析显示，在联合抗逆转录病毒治疗的第一年，TOX-MOD 的发病率随着年龄的增长而逐渐增加，但无统计学意义。在调整了性别、联合抗逆转录病毒治疗方案和联合抗逆转录病毒治疗开始年份的模型后，这种模式仍然存在。这些结果很重要，因为不仅患者的寿命更长，而且随着 HIV 的发展而衰老，而且老年人的新诊断病例也在增加。需要进行前瞻性研究来评估一线联合抗逆转录病毒治疗方案对老年人的安全性，特别是在资源有限的国家，这些国家最初的方案大多基于 NNRTI。
